Identity
- Trade Name
- RNA Medical® Full Range CO-Oximeter Control -level 3 EUDAMEDRNA FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, control FDA UDI
- Device Name
- RNA Medical QC 253 Full Range CO-Oximeter Control-level 3 EUDAMEDQC 253 Level 3 Carton FDA UDI
- Model / Reference
- QC253-level 3 EUDAMEDQC 253 Level 3 FDA UDI
- Description
- QC 253 Level 3 Carton FDA UDI
Identifiers
- Catalog Number
- QC 253-3 FDA UDI
- Primary DI / UDI-DI
- 10851290002475 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10851290002475 EUDAMED
- EMDN Code
- W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
- GMDN Term
- Total haemoglobin (totHb) IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total haemoglobin (totHb) IVD, control
Rna by Rna Medical Division — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Rna Medical Division
Sources (2)
- FDA UDI 41f2b756-b60a-4d4f-b1e8-a1d3299f84af 34 fields · synced Jul 8, 2026
- EUDAMED 6d3da7f5-7405-4f6b-9a38-2bfc416e5958 61 fields · synced Jun 18, 2026